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The role of Logbooks and Recordkeeping in Identifying Root Causes
The records in a lab – the logbooks for chemicals, reagents, and calibration solutions, sample preparation, instrument maintenance and calibration, and quality checks – all are time-oriented. This gives a window of cause-and-effect or coincidence that can provide clues. The sum of these, plus the symptoms of the non-compliance, can point out the likely root cause.Learning ObjectivesTracking down the cause o..
Risk Management for Medical Devices per ISO 14971
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or the environment during all stag..
Best Practices for a Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that y..
Engineering and the Quality Unit: Why Can’t We Get Along?
Often, different departments in biopharmaceutical companies have varying interpretations of their responsibility and authority. These interpretations can devolve into conflicts between different departments. Although the overall goals and targets of the production and manufacturing operation are understood, the individual interpretation of how to attain those goals and targets may be quite different.The eng..
Sample Reanalysis
Sample re-analysis may be required for numerous reasons. Assay failure is the most common and the clearest. Individual re-analysis is usually justified by the lack of internal standards or the failure to meet chromatographic parameters such as retention time or peak shape. In ligand binding assays and chromatographic assays, the color or peak height may exceed expectations or fall below expectations. These&..
Quality Unit (QU) Roles and Responsibility of Sponsor for Non-clinical and Clinical Studies
This comprehensive course is designed to provide an in-depth understanding of the evolving regulatory landscape and the critical role of the Sponsor's Quality Unit (QU) in non-clinical and clinical research. The course focuses on the enhanced responsibilities and requirements placed upon the QU to ensure compliance, integrity, and ethical conduct throughout the drug development process, from early-stage res..
Navigating the Complexities of Newer Technologies When Validating FDA-Regulated Systems
Advancements in technology have forced companies to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and have higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation, and maintaining a system ..
Cost Efficiency and Partnership Models in Contract Manufacturing
The pharmaceutical industry is undergoing a transformative phase, driven by increasing cost pressures, evolving regulatory requirements, and the need for faster time-to-market. In this dynamic environment, contract manufacturing organizations (CMOs) have emerged as critical partners for pharmaceutical companies, offering specialized expertise, scalable production capabilities, and cost-effective solutions. ..
Effective Technical Writing for FDA Submissions
Technical Writing for FDA Submissions is a critical skill for professionals in regulated industries, including pharmaceuticals, medical devices, and biotechnology. Regulatory submissions to the U.S. Food and Drug Administration (FDA) must be clear, precise, and well-structured to ensure compliance and facilitate regulatory review. Poorly written submissions can lead to delays, requests for additional inform..
FDA 483 or Warning Letter? Now what?
The training on “FDA 483 or Warning Letter – Now What?” is designed to empower professionals in FDA-regulated industries with the knowledge and skills necessary to respond effectively to regulatory challenges. FDA 483 observations and Warning Letters signify potential non-compliance issues that require immediate attention to avoid escalated enforcement actions. This webinar provides a comprehensive roadmap ..
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations
In this webinar, the attendees will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort but must be done with diligence.Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a raw material or packaging component used in conjunction with the product during the manuf..
A Disinfectant Field Trial that Meets Annex I Guidance
In this informative webinar, we will explore the key elements of a Contamination Control Strategy (CCS) implemented in a recent biopharma disinfectant field trial, following Annex I guidance. The case study highlights the use of a ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide to control bioburden in a new cleanroom operation post-construction.This webinar is ..
Applying Six Sigma "Downtime" in the Bioanalytical Lab
Applies the consideration of the acronym "DOWNTIME" to improve function and efficiency in the LAB. - Defects- reduce or eliminate - Overproduction reduces waste of materials, time, and personnel - Waiting to eliminate waiting on resource access or permission - Non-utilized resources- instruments, personnel - Transportation-movement (temporal or spatial) of resources/or documents&nbs..
Sampling by Variables (ANSI/ASQ Z1.9, formerly MIL-STD 414)
ANSI/ASQ Z1.9 (formerly MIL-STD 414) is an acceptance sampling plan that uses the average measurement of a sample, and its range or standard deviation, to determine whether a production lot should be accepted. This webinar will show how to select and use sample plans.Attendees will receive a pdf copy of the slides and accompanying notes, and an Excel spreadsheet that converts a traditional sampling plan i..
The Human Error Toolbox: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior can be managed, reducing the likelihood of these occurrences. When wor..